Sitagliptin Grindex 100 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Sitagliptina Grindeks 25mg Film-coated Tablets EFG

Sitagliptina Grindeks 50mg Film-coated Tablets EFG

Sitagliptina Grindeks 100mg Film-coated Tablets EFG

sitagliptin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Sitagliptina Grindeks is and what it is used for
2. What you need to know before taking Sitagliptina Grindeks
3. How to take Sitagliptina Grindeks
4. Possible side effects
5. How to store Sitagliptina Grindeks
6. Contents of the pack and other information

1. What is Sitagliptina Grindeks and what is it used for?

Sitagliptina Grindeks contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medicine to help you lower your blood sugar, which is too high due to your type 2 diabetes. This medicine may be used alone or in combination with other blood sugar-lowering medicines (insulin, metformin, sulfonylureas or glitazones) that you may already be taking for diabetes, along with a diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin, and the insulin your body does produce does not work as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems, such as heart disease, kidney disease, blindness, and amputations.

2. What you need to know before starting to take Sitagliptina Grindeks

Do not take Sitagliptina Grindeks

if you are allergic to sitagliptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with sitagliptin (see section 4).

If you notice blisters on your skin, this might be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptina.

Tell your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis);
• gallstones, alcohol addiction, or very high levels of triglycerides (a type of fat) in the blood. These conditions may increase the likelihood of developing pancreatitis (see section 4);
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes causing high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney problems currently or in the past;
• an allergic reaction to Sitagliptina (see section 4).

It is unlikely that this medicine will cause low blood sugar because it does not act when blood sugar levels are low. However, when this medicine is used in combination with a sulphonylurea or with insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of the sulphonylurea or insulin.

Children and adolescents

Children and adolescents under 18 years of age must not take this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is unknown whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptina Grindeks

Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.

In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm problems and other heart conditions). It may be necessary to monitor the level of digoxin in your blood if you are taking Sitagliptina.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take this medicine during pregnancy.

It is unknown whether this medicine passes into breast milk. You must not take this medicine if you are breast-feeding or plan to breast-feed.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or none. However, dizziness and somnolence have been reported, which may affect the ability to drive or use machines.

Taking this medicine together with medicines called sulphonylureas or with insulin may cause hypoglycaemia, which may affect the ability to drive and use machines or work without secure support.

Sitagliptina Grindeks contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; that is, essentially "sodium-free".

3. How to take Sitagliptina Grindeks

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• orally

If you have kidney problems, your doctor may prescribe you lower doses (such as 25 mg or 50 mg).

You may take this medicine with or without food and drinks. The 50 mg and 100 mg Sitagliptina film-coated tablets have a score line on one side. The score line is intended only to facilitate breaking the tablet for ease of swallowing, and not to divide the tablet into equal doses.

Your doctor may prescribe this medicine alone or together with other medicines that also lower blood sugar.

Diet and exercise can help your body use sugar more effectively. It is important that you follow the diet and exercise regimen recommended by your doctor while taking Sitagliptina.

If you take more Sitagliptina Grindeks than you should

If you take more of this medicine than prescribed, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sitagliptina Grindeks

If you miss a dose, take it as soon as you remember. If you remember only at the time of your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose of this medicine.

If you stop taking Sitagliptina Grindeks

Continue taking this medicine for as long as your doctor prescribes it, so that it can keep helping to control your blood sugar levels. You should not stop taking this medicine without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

STOP taking Sitagliptin and contact your doctor immediately if you notice any of the following serious adverse effects:

• Severe and persistent pain in the abdomen (stomach area) that may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

If you have a severe allergic reaction (frequency not known), including skin rash, hives, skin blisters/skin peeling, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe a treatment for the allergic reaction and switch your diabetes therapy.

Some patients experienced the following adverse effects after adding sitagliptin to metformin treatment:

Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting.

Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.

Some patients experienced various types of stomach discomfort when starting sitagliptin and metformin together (frequency classified as common).

Some patients experienced the following adverse effects while taking sitagliptin in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar.

Common: constipation.

Some patients experienced the following adverse effects while taking sitagliptin and pioglitazone:

Common: flatulence, swelling of hands or legs.

Some patients experienced the following adverse effects while taking sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or legs.

Some patients experienced the following adverse effects while taking sitagliptin in combination with insulin (with or without metformin):

Common: flu-like symptoms.

Uncommon: dry mouth.

Some patients experienced the following adverse effects while taking sitagliptin alone during clinical studies or during post-authorization use, alone and/or in combination with other diabetes medicines:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, osteoarthritis, arm or leg pain.

Uncommon: dizziness, constipation, itching.

Rare: decreased platelet count.

Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptina Grindeks

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the blister and carton following "EXP".

The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sitagliptina Grindeks

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptine hydrochloride monohydrate equivalent to 25 mg, 50 mg or 100 mg of sitagliptin.

• The other components are:

Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), croscarmellose sodium (E468), sodium stearyl fumarate (E485), magnesium stearate (E572).

Film coating of the tablet:

25 mg tablets:

Polyvinyl alcohol–macrogol graft copolymer (E1209)
Talc (E553b)
Titanium dioxide (E171)
Glyceryl monocaprylocaprate (type 1) (E471)
Polyvinyl alcohol (E1203)
Iron oxide yellow (E172)
Iron oxide black (E172)

50 mg tablets:

Polyvinyl alcohol–macrogol graft copolymer (E1209)
Talc (E553b)
Titanium dioxide (E171)
Glyceryl monocaprylocaprate (type 1) (E471)
Polyvinyl alcohol (E1203)
Iron oxide yellow (E172)

100 mg tablets:

Polyvinyl alcohol–macrogol graft copolymer (E1209)
Talc (E553b)
Titanium dioxide (E171)
Glyceryl monocaprylocaprate (type 1) (E471)
Polyvinyl alcohol (E1203)
Iron oxide yellow (E172)

Appearance of the product and contents of the pack

Sitagliptina Grindeks 25 mg: film-coated tablets are round, biconvex, light yellow in colour, marked with "25" on one side. The tablet has a diameter of approximately 6.0 mm.

Sitagliptina Grindeks 50 mg: film-coated tablets are round, biconvex, yellow in colour, marked with "50" on one side and a breakline on the other side. The tablet has a diameter of approximately 8.0 mm.

Sitagliptina Grindeks 100 mg: film-coated tablets are round, biconvex, yellow in colour, marked with "100" on one side and a breakline on the other side. The tablet has a diameter of approximately 10.0 mm.

Sitagliptina Grindeks 25 mg, 50 mg and 100 mg is available in blister packs containing 28, 56 or 98 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS
Krustpils iela 53
Riga, LV-1057
Latvia
Telephone: +371 67083205
Fax: +371 67083505
Email: [email protected]

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder

Grindeks Kalceks España, S.L.
C/ José Abascal, 58 – 2º Dcha.
Madrid, 28003, Spain

This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Sweden: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets
Austria: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg Filmtabletten
Belgium: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg comprimés pelliculés
Bulgaria: Ситаглиптин Гриндекс 25 mg, 50 mg, 100 mg филм-облечени таблети
Croatia: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmom obložene tablete
Czech Republic: Sitagliptin Grindeks
Denmark: Sitagliptin Grindeks
Estonia: Sitagliptin Grindeks
Finland: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg kalvopäällysteiset tabletit
France: SITAGLIPTINE GRINDEKS 25 mg, 50 mg, 100 mg comprimé pelliculé
Germany: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg Filmtabletten
Greece: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg επικαλυμμένα με λεπτό υμένιο δισκία
Hungary: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmtabletta
Ireland: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets
Italy: Sitagliptin Grindeks
Latvia: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg apvalkotas tabletes
Lithuania: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg plevele dengtos tabletės
Luxembourg: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmbeschichtete Pëllen
Netherlands: Sitagliptine Grindeks 25 mg, 50 mg, 100 mg filmomhulde tabletten
Norway: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmdrasjerte tabletter
Poland: Sitagliptin Grindeks
Portugal: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg comprimidos revestidos por película
Romania: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg comprimate filmate
Slovakia: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmom obalené tablety
Slovenia: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg filmsko obložene tablete
Spain: Sitagliptina Grindeks 25 mg, 50 mg, 100 mg comprimidos recubiertos con película EFG
United Kingdom: Sitagliptin Grindeks 25 mg, 50 mg, 100 mg film-coated tablets (Northern Ireland)

Date of latest review of this leaflet: 12/2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)